Screening Women for Functional Hypothalamic Amenorrhea (FHA)

NCT05410886 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-04-29

No results posted yet for this study

Summary

What do the investigators know already? Many women suffer loss of periods (amenorrhoea). One of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (FHA). FHA is difficult to diagnose and may be mistaken for other conditions causing period loss, such as polycystic ovarian syndrome (PCOS). This could cause delays in starting the correct treatment.

What is the justification for doing this study? Undiagnosed women with FHA are predisposed to complications related to low oestrogen levels, such as osteoporosis, bone fractures and infertility. The failure to accurately identify women with FHA and mislabel those women with FHA as having PCOS, may delay appropriate treatment. Treatment delay causes harm for affected women, including bone fractures and infertility.

What do the investigators propose? Improve the diagnosis of women with FHA by composing an assessment score, which could be used by women to improve the accuracy of diagnosing FHA. The investigators designed a questionnaire based on literature search, which can be used to identify women with FHA. A questionnaire-based study (on-line or in person) will be performed to identify risk of FHA, in women referred to hospital with period loss.

Conditions

  • Amenorrhea Secondary

Interventions

OTHER

Questionnaire

A questionnaire including up to 20 questions will be distributed to study participants. This questionnaire will be used to identify women with FHA.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • Channa Jayasean, PhD · Imperial College London

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2024-02-02
Completion
2024-02-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410886 on ClinicalTrials.gov